A group of leading gynecological experts has asked the Food and Drug Administration (FDA) to rescind or revise its 2014 guidance against the use of power morcellators in gynecological surgery.

The group, known as the Leiomyoma Morcellation Study Group, consists of 48 gynecologists, oncologists and advocates for women’s health. All members of the group signed onto a letter to the FDA addressing the risk of morcellation cancer.

The group says the agency’s warning against using power morcellators in gynecological surgery was based on incorrect data and could result in tens of thousands of women undergoing riskier and more involved surgical procedures than would otherwise have been necessary.

A power morcellator is a surgical device used to cut up and remove larger masses of tissue through small surgical incisions. In recent years, this type of device has seen particular use in certain gynecological procedures like hysterectomy and uterine fibroid surgery.

Performing these procedures laparoscopically avoids the drawbacks that would come with performing them via open abdominal surgery – drawbacks such as lengthier hospital stays, longer recovery times, and increased risk of infection.

Recently, however, this type of device has raised significant concern over its potential to inadvertently cut up cancerous tissue and spread it elsewhere in the body, causing the cancer to upstage. The FDA’s 2014 warning addressed this risk.

The federal agency estimated that “approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.”

The agency also noted that there is no reliable method for detecting uterine sarcomas prior to surgery in women who have uterine fibroids. While leiomyosarcoma can sometimes be confirmed after surgical removal of specimen tissue, it is difficult to identify prior to surgery. When there is reason to suspect the presence of cancer before surgery, surgeons are more likely to use open abdominal surgery to remove the tissue intact.

The study group’s open letter to the FDA cites statistics that appear to be contrary to the FDA’s estimate. The group cites studies that estimate the risk of spreading cancerous tissue during uterine fibroid surgery to be anywhere from 1 in 1,960 to 1 in 4,360. They say the FDA’s estimate appears to overstate the risk.

The FDA responded to the group’s letter via an email expressing continued satisfaction with its current recommendation. The agency says it appreciates the continued scientific dialogue about morcellation cancer and will notify the public if it decides to change its recommendations.

Power Morcellator Lawsuits

The risk of morcellation cancer has recently engendered a group of power morcellator lawsuits, several of which have been consolidated into a multidistrict litigation in a federal court in Kansas.

Generally, the plaintiffs in these power morcellator lawsuits argue that the manufacturers of these devices failed to adequately warn physicians and patients about the risk of morcellation cancer. They also say that the devices are inherently defective by design and should have been designed for use in conjunction with a bag to contain all morcellated tissue.